Long-term outcomes of primary biliary cholangitis in China
A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis
This project will follow about 4,000 people in China with primary biliary cholangitis to see how symptoms, disease stage, and treatments affect long-term survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Select A State Or Province) |
| Trial ID | NCT07149675 on ClinicalTrials.gov |
What this trial studies
This is a retrospective-prospective multicenter cohort enrolling roughly 4,000 PBC patients from ten centers across China, led by Beijing Friendship Hospital. Investigators will collect baseline clinical and laboratory data and perform longitudinal follow-up to record survival, disease progression, and treatment changes. Analyses will examine the effects of symptoms, disease stage, biochemical response to ursodeoxycholic acid (UDCA), and use of second-line therapies on long-term outcomes. The study excludes patients with other chronic liver diseases, active malignancy, or severe comorbidities and aims to generate prognostic models tailored to the Chinese population.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of PBC who can provide informed consent and adhere to follow-up, and who do not have the specified exclusionary liver diseases or severe comorbidities, are ideal candidates.
Not a fit: Patients with concurrent chronic hepatitis B or C, autoimmune hepatitis, drug-induced liver injury, other disqualifying liver diseases, active malignancy, severe organ failure, or incomplete baseline records are unlikely to benefit from the study results.
Why it matters
Potential benefit: If successful, the findings could help doctors better predict prognosis and tailor treatment plans for people in China with PBC.
How similar studies have performed: Several single-center cohorts in China have reported prognostic factors and shown that biochemical response to UDCA predicts survival, but large multicenter outcome data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis consistent with PBC. * Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up. Exclusion Criteria: * Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary/metabolic liver diseases. * Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy. * Incomplete baseline medical records or laboratory data.
Where this trial is running
Beijing, Select A State Or Province
- Liver Research Center, Beijing Friendship Hospital, Capital Medical University — Beijing, Select A State Or Province, China (Recruiting)
Study contacts
- Study coordinator: Jidong Jia
- Email: jia_jd@ccmu.edu.cn
- Phone: +86-10-63139246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.